Regional Anesthesia Following Pediatric Cardiac Surgery
Atrial Septal DefectVentricular Septal Defect2 moreThe purpose of this study is to evaluate pain control following pediatric cardiac surgery with the use of local anesthesia via an ultrasound guided regional anesthetic technique compared with surgeon delivered wound infiltration.
A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae...
Ventricular Septal DefectAtrioventricular Septal Defect1 moreThis is a randomized, double-blind, placebo controlled, multicenter study to compare the efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for congenital heart defects. Eligible patients undergoing repair of a large unrestrictive ventricular septal defect (VSD), a partial or complete atrioventricular septal defect (AVSD), or an ostium primum atrial septal defect (primum ASD) will be eligible for enrollment.
Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and...
Hypoplastic Left Heart SyndromeTotal Anomalous Pulmonary Venous Return8 moreThis clinical trial is studying the use of different levels of oxygen exposure during and after cardiopulmonary bypass in eligible infants to learn about its safety during heart surgery. In addition to having the various doses of oxygen, patients that participate will also have blood samples, ultrasounds of the head, and brain wave patterns monitored. The hypotheses of this trial are: that there will be no difference with regards to adverse events between the infants in the normoxia group compared to the infants in the standard of care group there will be a significant difference in the measured partial pressure of oxygen (PaO2) values between the two treatment groups. the use of normoxia during cardiopulmonary bypass and in the immediate post-operative period will result in clinically significant decrease in oxidative stress as measured by thiobarbituric acid reactive substances (TBARS) after cardiac surgery
Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder...
Ventricular Septal DefectsThe AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA) in September, 2007. This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER Muscular VSD Occluder.
A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech®...
Perimembranous Ventricular Septal DefectThe objective of this registry is to gain more insight on the clinical use of the Occlutech perimembranous VSD occluder.
Optical Tissue Identification for Myocardial Architecture
Ventricular Septal DefectComplete Atrioventricular Canal1 moreThe goal of this study is to test the hypothesis that fiberoptic confocal microscopy (FCM) imaging during repair of common congenital heart defects is a useful adjunct for avoidance of conduction abnormalities.
Trevisio Post-Approval Study
PFO - Patent Foramen OvaleASD - Atrial Septum Defect2 moreA single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™ Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of the Amplatzer™ Occluder Devices
Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases
Muscular Ventricular Septal DefectThe Occlutech® mVSD is indicated for percutaneous, transcatheter muscular ventricular septal defect closure device designed for the occlusion of hemodynamically significant muscular ventricular septal defects. The objectives of the study are: To confirm the efficacy of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects. To confirm the safety of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects.
Improving Care for Children With Congenital Heart Disease.
Heart Disease CongenitalVentricular Septal Defect5 moreEstablish a cardiovascular biomarker profile to help screening for congenital heart disease in infants and children as well as use non-invasive cardiac imaging in combination with such profiling to better predict the need for future cardiac interventions such as open heart surgery or cardiac catheter intervention selected types of with congenital heart disease.
Lifetech MFO Post-Market Clinical Follow-Up Study
Ventricular Septal DefectThe purpose of the study is to collect real world data on patient outcomes and evaluate the procedural success and performance of the Lifetech KONAR-MF™ VSD Occluder for patients with ventricular septal defect (VSD).